Chronic Kidney DiseasePhase 3NCT00436995
Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
A Phase 3 study testing Darbepoetin Alfa in people with Chronic Kidney Disease, run by Amgen.
Trial summary
The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Darbepoetin Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving dialysis for 3 months or more before enrollment.
- The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
- Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
- Adequate iron stores (serum ferritin equal to or greater than 100 ug/L
Who cannot join
- Uncontrolled hypertension
- Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
- Other hematological disorders
- Upper or lower GI bleed within the prior 6 months
About this study
Official title: A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.
- Conditions
- Chronic Kidney Disease
- Being tested
- Darbepoetin Alfa
- Keywords
- Dialysis, Anaemia
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin AlfaDrug
Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.
| Study group | Role | What they receive |
|---|---|---|
| Single | Other | Not described Receives: Drug: Darbepoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
Measured: 33 weeks
Secondary outcomes (4)
Q2W doses over duration of study.
Measured: 33 weeks
Hb values during the evaluation period.
Measured: 33 weeks
adverse events during study
Measured: 33 weeks
Hb Rate of Rise during study and excursions above 14g/dL
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startApr 2006
- Primary completionJan 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436995
- Sponsor's protocol ID
- 20050210
- Status last verified
- Jan 2011
- First submitted
- 15 Feb 2007
- Last updated
- 21 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
- ClinicalTrials.gov ID
- NCT00436995
- Acronym / sponsor ID
- 20050210
- Conditions
- Chronic Kidney Disease
- Keywords
- Dialysis, Anaemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Other | Drug: Darbepoetin Alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving dialysis for 3 months or more before enrollment.
- The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
- Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
- Adequate iron stores (serum ferritin equal to or greater than 100 ug/L
Key exclusion criteria (4 listed)
- Uncontrolled hypertension
- Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
- Other hematological disorders
- Upper or lower GI bleed within the prior 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darbepoetin AlfaAdministered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb. | Drug | Single |
Primary outcome
Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
Time frame: 33 weeks
4 secondary outcomes
Q2W doses over duration of study.
Time frame: 33 weeks
Hb values during the evaluation period.
Time frame: 33 weeks
adverse events during study
Time frame: 33 weeks
Hb Rate of Rise during study and excursions above 14g/dL
Time frame: 33 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2011.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Darbepoetin Alfa in people with Chronic Kidney Disease, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period. (time frame: 33 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2011.